FDA Announces 510(k) Changes

FDA Announces 510(k) Changes (HealthPointCapital)
FDA to improve most common review path for medical devices (FDA)
510(K) AND SCIENCE REPORT RECOMMENDATIONS:   SUMMARY AND OVERVIEW OF COMMENTS AND NEXT STEPS (FDA)
FDA will implement 25 actions during 2011 to improve the 510(k) review process for medical devices.  Key actions include:

Streamlining the “de novo” review process for certain innovative, lower-risk medical devices,
Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process,
Establi...